Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT00680745
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 597
- Type 2 Diabetes
- Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
- Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
- Type 1 Diabetes
- Hepatic (liver) impairment
- Renal (kidney) failure or dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 pioglitazone hydrochloride dapagliflozin 2.5mg + Glimepiride 1 Rosiglitazone dapagliflozin 2.5mg + Glimepiride 2 dapagliflozin dapagliflozin 5mg + Glimepiride 2 Glimepiride dapagliflozin 5mg + Glimepiride 2 pioglitazone hydrochloride dapagliflozin 5mg + Glimepiride 3 pioglitazone hydrochloride dapagliflozin 10mg + Glimepiride 4 Glimepiride Placebo + Glimepiride 4 metformin hydrochloride Placebo + Glimepiride 4 pioglitazone hydrochloride Placebo + Glimepiride 1 dapagliflozin dapagliflozin 2.5mg + Glimepiride 1 Glimepiride dapagliflozin 2.5mg + Glimepiride 1 metformin hydrochloride dapagliflozin 2.5mg + Glimepiride 2 metformin hydrochloride dapagliflozin 5mg + Glimepiride 3 dapagliflozin dapagliflozin 10mg + Glimepiride 2 Rosiglitazone dapagliflozin 5mg + Glimepiride 3 Glimepiride dapagliflozin 10mg + Glimepiride 3 metformin hydrochloride dapagliflozin 10mg + Glimepiride 3 Rosiglitazone dapagliflozin 10mg + Glimepiride 4 Rosiglitazone Placebo + Glimepiride
- Primary Outcome Measures
Name Time Method Adjusted Mean Change in HbA1c Levels Baseline to Week 24 To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% At Week 24 To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c \< 7% after 24 weeks of treatment, compared to placebo plus glimepiride.
Adjusted Mean Change in Body Weight Baseline to Week 24 To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise Baseline to Week 24 To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2 Baseline to Week 24 To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.
Adjusted Mean Change in Fasting Plasma Glucose (FPG) Baseline to Week 24 To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.
Trial Locations
- Locations (1)
Research Site
🇺🇦Zaporozhye, Ukraine